FDA approves Tofidence, a biosimilar referencing Actemra

Roche’s primary patents for Actemra/RoActemra (tocilizumab) have already expired in major markets, including Europe and the US. On 29 September 2023, according to a Biogen press release, the FDA approved Tofidence (tocilizumab-bavi, BIIB00) as the first biosimilar referencing the IL-6 receptor antagonist tocilizumab for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

The attractiveness of Roche’s blockbuster as a target for biosimilar developers mirrors the patterns seen with other highly successful blockbuster drugs such as AbbVie’s Humira (adalimumab) and Amgen’s Enbrel. Bio-Thera’s CEO, Shengfeng Li, emphasised the significance of the company’s achievement: Tofidence not only marks the first FDA approval of a tocilizumab biosimilar in the US, but also represents Bio-Thera’s entry into this market. The milestone is expected to have a substantial impact on their presence and visibility. As Li stated: “The approval of Tofidence is a landmark achievement for Bio-Thera as it marks Bio-Thera’s first FDA approval for a product in the United States.”

Tofidence’s regulatory milestone is the outcome of a partnership between Biogen and Bio-Thera. The biosimilar was originally developed by Bio-Thera and will be commercialised by Biogen on a global scale (excluding China, which includes Hong Kong, Macau and Taiwan). The partnership represents a strategic move from Bio-Thera in the biosimilars market, considering that Actemra/RoActemra was a weighty revenue source for Roche, with global sales surging to nearly $4.0 billion in 2021, as stated in GlobalData’s Sales and Forecast database.

Even though RA is a heavily saturated market with respect to available therapies, the number of patients affected by this indication each year has been on the rise. As stated in a report by GlobalData titled Rheumatoid Arthritis: Market Analysis and Forecasts to 2029 – Forecast Update, published in December 2021, within the eight major markets (8MM) – Australia, France, Germany, Italy, Japan, Spain, the UK and the US – the US holds the dominant position. In 2019, approximately 1.6 million cases of RA were diagnosed in the US, contributing to total sales of approximately $18.7 billion, representing 71.9% of the global market.

This US market value is expected to grow to $21.2 billion at a compound annual growth rate of 1.3% from 2019 to 2029. Alongside Tofidence, with the approval of tocilizumab biosimilars such as Fresenius Kabi’s TYNEE and the emergence of late-stage biosimilar candidates such as Celltrion’s CT-P47, the biosimilars landscape for RA is changing. A combination of events, including biosimilar erosion and anticipated launches of late-stage pipeline agents, is expected to cause Actemra’s sales to decrease at a CAGR of 3.0% from 2019 to 2029 for RA. Tocilizumab biosimilar sales are poised to increase significantly, with sales expected to reach a value of approximately $339.0 million in 2029 in the US, positioning Bio-Thera favourably for monetisation there.